Accord Healthcare recalls specific Rosuvastatin 20mg tablets (NDC 16729-286-15 and 16729-286-17) after FDA inspection found manufacturing deviations. Consumers should check product labels for batch numbers and expiration dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling certain Rosuvastatin 20mg tablets after an FDA inspection found manufacturing deviations. This recall affects specific packaging and batch numbers that may pose risks if used as intended.
The recall is due to FDA finding manufacturing deviations during an inspection. This means the tablets may not meet quality standards, potentially affecting safety and effectiveness. However, the exact risk to consumers is not specified in the recall notice.
People who have the recalled Rosuvastatin tablets (90-count or 1,000-count bottles) with specific NDC numbers and batch dates. Those taking statins for cholesterol management are most at risk.
Check for the 90-count bottle with NDC 16729-286-15 or 1,000-count bottles with NDC 16729-286-17. Look for batch numbers like P2006560 or later, and expiration dates listed on the packaging.
Look for the NDC number (16729-286-15 or 16729-286-17) and batch numbers on the tablet packaging.
The FDA found manufacturing deviations during an inspection, which means the tablets may not meet quality standards.
The recall notice does not specify a remedy, so contact Accord Healthcare directly for guidance.
Yes, but the recall notice lists many batch numbers; check the product label for the specific batch number and expiration date.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0406-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0406-2023 from Accord Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
